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Cell and Gene Therapy Quality Assurance Specialist
3 weeks ago
This is a quality assurance role that involves overseeing the manufacturing process of cell and gene therapy products. The ideal candidate will have experience in GMP QA/Quality and be proficient in quality systems, electronic document systems, and eQMS.
Responsibilities- Initiate, investigate, and close deviations, and manage CAPA processes including effectiveness checks.
- Review, assess, and manage change controls related to materials, equipment, processes, and documentation.
- Perform thorough review of executed batch manufacturing records, critical logbooks, and associated documentation.
- Provide real-time QA support on the manufacturing floor during production, aseptic operations, and changeovers.
- Review, revise, and approve GMP documentation including Standard Operating Procedures (SOPs), Master Batch Records (MBRs), and work instructions.
- Conduct gap assessments of processes and procedures against current GMP and regulatory expectations.
- Support internal and external audits including preparation, hosting, documentation retrieval, and response drafting.
- Participate in continuous improvement initiatives and cross-functional project teams to enhance quality systems and operational efficiency.
- Collaborate with manufacturing, QC, validation, and engineering teams to ensure timely execution of quality deliverables.
- Support inspection readiness activities and promote a strong culture of compliance and quality awareness.
- Train and mentor operations staff on quality procedures and best practices as needed.
- Utilize electronic Quality Management Systems (eQMS) to manage quality workflows and records.
- Support Quality Control function as needed, including review of QC documentation, data trending, and investigations.
- Bachelor's or Master's in Life Sciences, Biotechnology, Pharmacy or equivalent.
- 3–5 years of GMP QA/Quality experience, preferably in Cell & Gene Therapy, Biologics, or ATMP manufacturing.
- Experience in working in cell and gene therapy manufacturing is an added advantage.
- Strong knowledge of cGMP, GDP, FDA/EMA standards, PIC/S, ICH Q7/Q9, Annex 1, data integrity principles.
- Proficiency with quality systems (deviation, CAPA, change control, document control, batch release etc).
- Familiar with eQMS, and electronic document systems.
- Excellent communication, analytical, problem‐solving, and collaborative skills.
- Able to work independently and under tight timelines; experience in Q&A shop‐floor oversight.
- Proficient in MS Office Suite (Microsoft Word, PowerPoint, Excel).
- Strong team player with a strong set of interpersonal skills.
- Excellent written and verbal communication skills.
We are a company that provides innovative solutions for life sciences and biotechnology industries. Our goal is to improve the quality of life by providing cutting-edge products and services.
